LEARNING OBJECTIVESThe Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity. At the conclusion of this activity, participants should be able to:

Identify the causes of restenosis, specifically in-stent restenosis.

Recognize the medical and economic burden of in-stent restenosis.

Understand the success and limitation of the current approved therapy for treating in-stent restenosis.

Describe the concept of drug-eluting stents, including mechanism of action, various drugs used, and degree of benefit regarding anticipated restenosis reduction.

Understand the anticipated economic impact of coated stents and how the short-term cost of these devices is balanced by a reduction in the need for repeated procedures, including the strategy of universal employment vs targeted use for high-risk procedures.

ACCREDITATION STATEMENTThe Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to sponsor continuing medical education for physicians.

CREDIT DESIGNATION STATEMENTThe Johns Hopkins University School of Medicine designates this educational activity for a maximum of 2 category 1 credits toward the AMA Physician's Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity.

The estimated time to complete this educational activity: 2 hours.

Release date: June 15, 2003. Expiration date: June 15, 2005.

DISCLAIMER STATEMENTThe opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects, before administering pharmacologic therapy to patients.

This program is supported by an unrestricted educational grant from Cordis Corporation, a Johnson & Johnson Company.

Full Disclosure Policy Affecting CME Activities:As a sponsor accredited by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of Johns Hopkins University School of Medicine to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. Program Director and Participating Faculty reported the following:

PROGRAM DIRECTOR

Jeffrey A. Brinker, MD, FACCProfessor of Medicine and RadiologyDepartment of Medicine and RadiologyDivision of CardiologyJohns Hopkins UniversitySchool of MedicineBaltimore, Maryland• Dr Brinker reports having no financial or advisory relationships with corporate organizations related to this activity.

Notice:In accordance with the ACCME Standards for Commercial Support, the audience is advised that one or more articles in this continuing medical education activity may contain reference(s) to unlabeled or unapproved uses of drugs or devices.

Faculty have indicated that they have not referenced unlabeled/unapproved uses of drugs or products.

Advanced Studies in Medicine provides disclosure information from contributing authors, lead presenters, and participating faculty. Advanced Studies in Medicine does not provide disclosure information from authors of abstracts and poster presentations. The reader shall be advised that these contributors may or may not maintain financial relationships with pharmaceutical companies.

The practice of percutaneous coronary intervention has undergone considerable evolution since the first procedures were described by Gruntzig in 1978. The initial acute success rate of about 60% has increased to approximately 95%, while the principal complication (ie, the need for emergency surgery) has decreased from about 5% to 0.5%. Remarkably, these results have been achieved despite the inclusion of sicker patients with more complicated coronary disease. Much of this progress can be attributed to the innovative devices, techniques, and adjuvant drugs introduced over the last quarter of the century to address the many challenges to coronary angioplasty. Interventionalists have had the luxury of picking and choosing the particular tools thought best for their patients. Over time, those tools that have contributed most to the safety and efficacy of the procedure have been widely incorporated into practice, while others have been relegated to infrequent niche application or are no longer used. As coronary intervention has become more sophisticated, the cost of performing the procedure has increased. The overall impact of incremental additions in cost has been magnified by the increasing numbers of patients undergoing this form of revascularization and, quite correctly, attention has been directed at issues of cost effectiveness.

The recent approval of the first drug-eluting stent highlights the complexity of evaluating the role of a highly effective device that is associated with a significant increase in cost. Designed to overcome all 3 elements of the restenotic process, which currently complicates the course of 15% to 20% of patients undergoing coronary intervention, this device combines the support properties of the bare-metal stent with the antiproliferative action of a drug applied directly at the site of vessel injury. Controlled trials confirm dramatic reductions in clinical and angiographic manifestations of restenosis when these devices are used. Drug-eluting stents, however, are approximately 3 times more expensive than bare-metal stents and require more prolonged aggressive antiplatelet therapy, which adds to the cost. Furthermore, the prospect of essentially eliminating restenosis would shift some patients away from bypass surgery adding to the overall number of patients undergoing coronary intervention. The economic implications of drug-eluting stents to the healthcare system in general, and to the hospital, patient, and third-party insurers specifically, are profound.

This issue of Advanced Studies in Medicine features a symposium in which both the clinical and economic implications of drug-eluting stents are examined. In their article titled "A Review of Drug-Eluting Stents: Why All the Excitement?" Martin B. Leon, MD, and Jeffrey W. Moses, MD, discuss the pathogenesis, incidence, and treatment of restenosis. The 2 most extensively evaluated drug coatings, sirolimus and paclitaxel, are reviewed and the benefits and possible limitations of these agents examined.

In an accompanying paper, Rodolphe Ruffy, MD, FACC and Raymond J. Kaden, CPA, estimate the potential cost effectiveness of drug-eluting stents using a decision-analytic model in their article titled "Projected Health and Economic Benefits of the Use of Sirolimus-Eluting Coronary Stents." Earl P. Steinberg, MD, MPP, provides a clinical-economic perspective of the anticipated effects that drug-eluting stents will have on the treatment of patients with coronary disease and the healthcare system that must provide them.

The information provided in this issue should provide some perspective from which clinicians and decision makers may view what many consider the advent of a new age of coronary intervention.

*Professor of Medicine and Radiology, Department of Medicine and Radiology, Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland.